www.fdanews.com/articles/203354-roches-neuromyelitis-optica-drug-enspryng-wins-eu-approval
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Roche’s Neuromyelitis Optica Drug Enspryng Wins EU Approval
June 29, 2021
Roche has secured European Commission approval for Enspryng (satralizumab) for treating adolescents and adults with neuromyelitis optica spectrum disorder (NMOSD), a central nervous system condition that can cause blindness, paralysis and painful spasms.
The drug, which the commission authorized as either a monotherapy or combined with immunosuppressive therapy, is administered subcutaneously every four weeks.
The approval was supported by two phase 3 studies which showed the drug offered “robust and sustained efficacy” in reducing the risk of disease relapse. Enspryng works by binding and blocking the interleukin-6 receptor that causes inflammation linked with NMOSD.
The treatment received FDA approval for the same indication in August.